New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)
Date: January 21, 2024
Duration: 60 Minutes
Time: 12 PM EST
FDA has expressed its desire to create rules to better regulate LDTs. This seminar will discuss the current rules and practical tips for being compliant to the current rules. The instructor will provide advice based on his extensive regulatory experience on the best and worst case scenarios for various kinds of LDTs under current regulations. This seminar is intended for general instructions to all LDT providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA regulates LDTs.
Areas Covered in the Session:
- Definition of LDTs and differences and similarities with other diagnostics
- Current FDA regulations and guidance documents
- Documentation required
- Quality systems currently applicable to LDT providers
- Labeling and marketing practices
Who will benefit:
- Senior management of LDT providers
- Project Managers
- Regulatory Vice Presidents, Directors and Managers
- Lab testing professionals
- Compliance professionals
- Auditors
- Attorneys – In-house or Outside Counsel
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.